Recently, I just found that the FDA has an email address for questions and answers regarding GCP questions. The original questions along with FDA's responses are posted on the web. While FDA's responses may not directly address the original questions being asked, Replies to Inquiries to FDA on Good Clinical Practice is still a great resource.
Friday, October 25, 2013
Replies to Inquiries to FDA on Good Clinical Practice
Good Clinical Practice (GCP) is the law of conducting the clinical trials. Sometimes, interpreting the law is challenging, the same is true in interpreting the GCP and other regulatory guidelines. FDA has set up an Office of Good Clinical Practice and provided Good Clinical Practice Contacts for helping interpreting the GCP and answering the GCP related questions.
Recently, I just found that the FDA has an email address for questions and answers regarding GCP questions. The original questions along with FDA's responses are posted on the web. While FDA's responses may not directly address the original questions being asked, Replies to Inquiries to FDA on Good Clinical Practice is still a great resource.
Recently, I just found that the FDA has an email address for questions and answers regarding GCP questions. The original questions along with FDA's responses are posted on the web. While FDA's responses may not directly address the original questions being asked, Replies to Inquiries to FDA on Good Clinical Practice is still a great resource.
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2 comments:
It is really amazing to know that FDA answers for the doubts and Good Clinical Practice related queries in the web for the professionals.
This work will definitely be useful to many medical professionals. As, the questions on Good Clinical Practice has been directly replied by the FDA.
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